Hydroxypropyl Cellulose Ocular System, chemical structure, molecular formula, Reference Standards

Hydroxypropyl Cellulose Ocular System

»Hydroxypropyl Cellulose Ocular System contains not less than 85.0percent and not more than 115.0percent of the labeled amount of Hydroxypropyl Cellulose.It contains no other substance.It is sterile.

Packaging and storage— Preserve in single-dose containers,at a temperature not exceeding 30

USP Reference standards á11ñ— USP Hydroxypropyl Cellulose RS.

Identification— Prepare a 1in 100solution in methanol,based on the labeled amount of Hydroxypropyl Cellulose.Evaporate 2drops of the solution on a silver chloride plate so that it forms a thin film:the IRabsorption spectrum of the film so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Hydroxypropyl Cellulose RS.

Sterility á71ñ: meets the requirements.

Weight variation— Determine the weight of each of a sufficient number of Systems.Not more than 1out of 20varies more than 25%from the average or,failing that,not more than 6out of 60(including the original 20)vary more than 25%(but none more than 35%)from the average weight.

Assay—

Standard preparation— Dissolve with agitation an accurately weighed quantity of USP Hydroxypropyl Cellulose RSin water to obtain a solution having a known concentration of about 0.05mg per mL.

Assay preparation— Transfer a sufficient number of Ocular Systems,to provide about 25mg of hydroxypropyl cellulose,to a 500-mLvolumetric flask,add about 250mLof water,and dissolve with agitation on a mechanical shaker.Dilute with water to volume,and mix.

Procedure— Separately pipet 2mLof the Standard preparation,the Assay preparation,and water,to provide a blank,into individual 50-mLcentrifuge tubes.Add to each tube 6.0mLof a 1in 2000solution of anthrone in sulfuric acid,and mix on a vortex mixer.After 40minutes,again mix,and concomitantly determine the absorbances of the solutions obtained from the Standard preparationand the Assay preparationat 620nm,with a suitable spectrophotometer,against the solution from the blank.Calculate the quantity,in mg,of hydroxypropyl cellulose in each Ocular System taken by the formula:

(500)(C/N)(AU/AS),

in which Cis the concentration,in mg per mL,of USP Hydroxypropyl Cellulose RSin the Standard preparation;Nis the number of Ocular Systems taken for the Assay;and AUand ASare the absorbances of the solutions from the Assay preparationand the Standard preparation,respectively.

Auxiliary Information— Staff Liaison:Justin Lane,B.S.,Scientific Associate

Expert Committee:(EMC)Excipients:Monograph Content

USP28–NF23Page 979

Phone Number:1-301-816-8323